PER-031-23尚未招募3 期
A Phase 3 Randomized, Placebo-Controlled Clinical Study to Evaluate the Efficacy and Safety of MK-0616 in Reducing Major Adverse Cardiovascular Events in Participants at High Cardiovascular Risk
Merck Sharp & Dohme LLC., (una subsidiaria de Merck & Co. Inc.)0 个研究点目标入组 0 人开始时间: 2024年3月14日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •Type of Participant and Disease Characteristics: Is on a stable dose of all background LLTs (including statin and nonstatin agents) for at least 30 days before Visit 1 (Screening) with no medication or dose changes planned during the participation in the study.
- •Demographics: Is an individual of any sex/gender, who meets the age criteria as defined in Inclusion #1 [Type of Participant and Disease Characteristics: Meets the criteria for at least 1 of the following ASCVD event risk categories (A or B) ] at the time of providing informed consent.
- •Female Participants: A participant assigned female sex at birth is eligible to participate if not pregnant or breastfeeding, and at least one of the following conditions applies:
- •Is not a POCBP.
- •Is a POCBP.
- •Informed Consent: The participant (or legally acceptable representative) has provided documented informed consent/assent for the study. The participant may also provide consent/assent for FBR. However, the participant may participate in the study without participating in FBR.
- •Note: Refer to Appendix 7 for country-specific requirements.
- •Type of Participant and Disease Characteristics: Meets the criteria for at least 1 of the following ASCVD event risk categories (A or B):
- •A. History of Major ASCVD Event:
- •Age =18 years with a history of a major ASCVD event defined as at least 1 of the following (i-iii):
- •i. =30 days post MI (presumed Type 1 due to plaque rupture or erosion).
- •ii. =30 days post ischemic stroke (presumed due to atherosclerosis).
- •iii. =30 days post successful peripheral (carotid or lower extremity) arterial revascularization (surgical or endovascular) or major (ankle or above) amputation due to atherosclerosis.
- •B. High Risk for First Major ASCVD Event and Not Meeting Criteria for A:
- •High risk for first major ASCVD event defined as at least 1 of the following (i-v):
- •i. Age =50 years with evidence of CAD:
- •History of multivessel disease (=2 vessels with =50% stenosis), with or without revascularization, or
- •Significant unrevascularized single-vessel disease (=50% stenosis of the left main coronary artery or =70% stenosis of any other single coronary artery), or
- •CT coronary artery calcification score =300 Agatston units in a participant without a coronary revascularization prior to randomization.
- •ii. Age =50 years with evidence of atherosclerotic cerebrovascular disease:
- •Prior TIA with =50% ipsilateral carotid stenosis, or
- •Carotid artery stenosis of =70% in at least 1 artery or =50% in both arteries.
- •iii. Age =50 years with evidence of PAD:
- •=50% stenosis in an infra-inguinal leg artery (eg, femoral, superficial femoral, popliteal, tibial) due to atherosclerosis, or
- •Symptoms of claudication attributed to vascular disease with an ankle brach
排除标准
- •Non-cardiac medical conditions: Has a history of nephrotic syndrome.
- •Non-cardiac medical conditions: Has history of severe renal insufficiency defined as eGFR <30 mL/min/1.73 m2 at Visit 1 (Screening) or has ESRD on dialysis. eGFR will be calculated according to Appendix 2.
- •Note: Refer to Appendix 7 for country-specific requirements.
- •Other Exclusions: Has a recent history of drug abuse (within the last year) or is a current user of illicit drugs at the time of Visit 1 (Screening).
- •Cardiovascular medical conditions: Has a history of homozygous FH based on genetic or clinical criteria, compound heterozygous FH, or double heterozygous FH.
- •Cardiovascular medical conditions: Has New York Heart Association Class IV heart failure, last known Left Ventricular Ejection Fraction =25% by any imaging method, or had a Heart Failure hospitalization within 3 months before Visit 1 (Screening).
- •Cardiovascular medical conditions: Has recurrent ventricular tachycardia within 3 months prior to randomization.
- •Cardiovascular medical conditions: Has QTc =500 ms (in the absence of intraventricular conduction delay and/or bundle branch block) based on an ECG performed within 6 months before or at Visit 1 (Screening).
- •Cardiovascular medical conditions: Has uncontrolled hypertension defined as sitting SBP >160 mm Hg or DBP >100 mm Hg at Visit 2 (Randomization) despite stable antihypertensive treatment.
- •Other Exclusions: Has a medical disorder, condition, or history thereof that in the opinion of the investigator would impair the participant’s ability to participate in or complete the study.
- •Cardiovascular medical conditions: Has a planned arterial revascularization procedure.
- •Non-cardiac medical conditions: Has any clinically significant malabsorption condition based on principal investigator’s assessment (eg, recurrent vomiting, inflammatory bowel disease with ongoing symptoms, chronic intestinal disease accompanied by a disturbance in digestion absorption, or a history of extensive resection of the upper GI tract).
- •Non-cardiac medical conditions: Has laboratory or clinical evidence of clinically significant hepatic conditions, including 1 or more of the following:
- •ALT or AST =3x ULN at Visit 1 (Screening).
- •Direct bilirubin >2x ULN at Visit 1 (Screeni
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